Greater vigilance is to be applied while comparing trademarks relating to drugs and pharmaceutical products, yet there is an alarming prevalence of identical/similar drug names in India’s healthcare system.It has become standard practice for brand names being devised from the names of the underlying active pharmaceutical ingredients, which can lead to confusion since several active ingredients may have different usage in different combinations.

In the case of Cadila Healthcare Ltd. v/s Cadila Pharmaceutical Ltd, 2001(5) SCC 73, the Supreme Court cautioned future courts not to place undue reliance on doctors or pharmacists, noting that they may not be immune from misunderstandings or errors, particularly where marks are confusingly similar and pertain to pharmaceuticals with comparable active pharmaceutical ingredients.

Further confusing the medico legal landscape with respect to trademarks, there are examples of coexisting similar trademarks, for drugs having different active ingredients. In the case of Sun Pharmaceutical Industries v. Anglo-French Drugs and Industries Limited (2014:DHC :4617-DB), the trademark OXETOL was used for curing bipolar disorder and epilepsy, while the mark EXITOL was used for treating constipation. The Delhi High Court held that a slight semblance in the phonetic pronunciation between two marks cannot automatically satisfy the test of confusion in a person with average intelligence, considering both the drugs were Schedule H drugs that could only be sold on prescriptions. The resemblance between such medications increases the likelihood of errors, as individuals may inadvertently substitute one medication for another.

In Sun Pharmaceuticals Industries Limited. Vs. M/s West Coast Pharmaceuticals AIR 2012 Gujarart 142 the Appellant challenged the Respondent’s acidity drug ACICAL, claiming the drug sounded similar to its own brand ACUCAL meant for pregnant women. While ACUCAL was derived from the words ‘Accurate and Calcium’, ACICAL was coined from the words “Acidity and Calcium”. The rival marks were used to treat different diseases, since ACUCAL is recommended as a calcium supplement for lactation during pregnancy, while ACICAL is administered as a calcium drug to treat acidity and heartburn. Even the ingredients were different as ACUCAL contained the chemical compound calcium citrate, vitamin D-3 and magnesium, while ACICAL contained calcium carbonate. The Gujarat High Court observed that coupled with other factors like difference in ingredients, its use, effect and price, both the drugs are Schedule-H drugs and hence the possibility of any mistake or error is almost nil.

However, recently in Glenmark Pharmaceuticals Ltd vs Sun Pharma Laboratories Ltd. FAO(OS) (COMM) 146/ 2023, the appellant challenged the interim injunction against use of the mark INDAMET. The trademark ISTAMET was in use for a drug containing salts, ‘Metformin Hydrochloride’ and ‘Sitagliptin Phosphate Monohyrdrate’, and is used to treat diabetes. Whereas, the mark INDAMET is derived from the constituent chemical compounds, i.e., ‘INDA’ from “Indacaterol acetate” and “MET” from “Mometasone furorate” and would need a DPI device for its intake and is meant for asthma. It was held that the competing marks, ISTAMET and INDAMET are structurally and phonetically similar and merely because one product was to be consumed with the aid of a DPI device, would not constitute a justifiable ground for refusal of injunction. The Court cannot discount the potential for confusion or misunderstanding when ordinary consumers are faced with similar-looking prescription drugs, even if their therapeutic applications differ significantly. It is thus critical that the public is not misled into purchasing a product under the belief that it has a specific composition or formulation, only to discover it contains different active ingredients. A purchaser of average intelligence cannot be expected to break down tradenames or undertake such an exercise at the time of the transaction.

In an effort to curb the existence identical/similar drug names and regulate brand names, the Ministry of Health brought in the Drugs and Cosmetics (Thirteenth Amendment) Rules, 2019, requiring the Applicant for a manufacturing license to provide an undertaking that the trade name or brand name they employ won’t cause any confusion or deception in the market and that searches for similar names have been carried out before the Trademarks Registry, central database for brand name or trade name of drugs maintained by Central Drugs Standard Control Organisation (CDSCO), literature and reference books on details of drug formulations in India, and the internet. Yet there are many identical/similar drugs in India that can result in medication errors, for instance drugs such as metformin for diabetes, metoprolol for heart conditions, and metronidazole for amoebiasis, often referred to as Met, Meto, and Metro, respectively, demand heightened attention due to potential for confusion.

Even the National Human Rights Commission (NHRC), has taken suo motu cognizance[1] of a newspaper article that a large number of drugs are sold in India with identical brand names for treating different conditions. Examples of identical brand names for different active ingredients include the brand names ‘Linamac 5’ and ‘Linamac’, which are used to treat multiple myeloma and diabetes respectively. Further, different variations of the trademark ‘Medzol’ are used by four companies selling different drugs aiming to target a different problem, ranging from sedatives to acidity treatment to deworming treatment and antifungal medication. The NHRC stated that “Reportedly, the consequences of confusion between these medications at the pharmacy can be serious for patients as these drugs are being prescribed by the doctors for treatment of different diseases. Reportedly, the Central Drugs Standard Control Organization (CDSCO) would first have to build a database of all pharmaceutical brand names by collecting data from the 36 different Drug Controllers in each State and Union Territory as there is no such database in the country. Also, no data on prescription errors is being maintained by the authorities.”

It is a reality that pharmacists typically dispense medications without a prescription/ based on illegible prescriptions/ telephonic or e-prescriptions in India. Therefore, better regulation of trademarks within the pharmaceutical sector is the need of the hour.


Authors: Christine Chiramel and Prachi Sachar


Footnotes

[1] https://nhrc.nic.in/media/press-release/nhrc-takes-suo-motu-cognizance-newspaper-article-large-number-drugs-being-sold

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